Data / Medical devices / United States / Pacific Surgical Specialties
Pacific Surgical Specialties: FDA-registered device maker in Spokane, WA, United States, 1 510(k) clearance
Pacific Surgical Specialties is registered with the FDA (registration 3011586151) in Spokane, WA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 11, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011586151
- Address
- 11616 E Montgomery Ave Suite 14, Spokane, WA, United States, 99206
- Owner or operator
- PACIFIC11 (10049790)
- Roles
- Complaint file establishment
- First device listed
- October 19, 2016
- Registered through
- 2026
- Brand names listed
- FAS - ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL, GEI - Electrosurgical, cutting & coagulation & accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Electrosurgical, Active, Urological | FAS | 2 | Complaint file establishment | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 11, 2016 | K153055 | ACE Electrosurgical Resection and Vaporization Electrodes Series | GEI | Substantially Equivalent | Ace Medical Devices Pvt. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Electrode, Electrosurgical, Active, Urological
Updated July 11, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.